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Exercise After Intensive Care Unit: a Randomised Controlled Trial (REVIVE)

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ClinicalTrials.gov Identifier: NCT01463579
Recruitment Status : Completed
First Posted : November 2, 2011
Last Update Posted : December 14, 2015
Sponsor:
Collaborator:
Belfast Health and Social Care Trust
Information provided by (Responsible Party):
Brenda O'Neill, University of Ulster

Tracking Information
First Submitted Date  ICMJE September 8, 2011
First Posted Date  ICMJE November 2, 2011
Last Update Posted Date December 14, 2015
Study Start Date  ICMJE December 2011
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 1, 2011)
Physical Functioning subscale of the SF-36 [ Time Frame: 6 weeks ]
The primary outcome measure will be physical function as measured by the physical functioning (PF) subscale of the SF-36v2 following the exercise programme. This is an important outcome that is meaningful to patients. This has been shown to be an acceptable, reliable and valid tool following critical illness.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 1, 2011)
  • Physical Functioning Subscale of the SF-36 [ Time Frame: 6 months ]
  • Rivermead Mobility Index [ Time Frame: 6 weeks, 6 months ]
    Physical Function will also be measured using the Rivermead Mobility Index.
  • Hand Dynamometry [ Time Frame: 6 weeks, 6 months ]
    Patients have indicated to us that hand function is particularly slow to return after critical illness and that this is important to them. Strength and dexterity will specifically be measured by dynamometry and the Nine Hole Peg Test.
  • The Nine Hole Peg Test [ Time Frame: 6 weeks, 6 months ]
    Patients have indicated to us that hand function is particularly slow to return after critical illness and that this is important to them. Strength and dexterity will specifically be measured by dynamometry and the Nine Hole Peg Test.
  • Incremental Shuttle Walk Test [ Time Frame: 6 weeks, 6 months ]
    Exercise capacity will be measured with the Incremental Shuttle Walk Test (ISWT). This is a valid and standardised test of exercise capacity which is responsive to exercise based interventions in other populations. Furthermore the ISWT was used in our pilot study and demonstrated the feasibility and responsiveness of this measure.
  • Functional Limitations Profile [ Time Frame: 6 weeks, 6 months ]
    Health related quality of life (HRQoL) will also be measured using Functional Limitations Profile (FLP) questionnaire. The FLP questionnaire is a well validated and widely used generic instrument to measure health status in a variety of conditions including critical illness. It provides an estimate of sickness related dysfunction and has both physical and psychosocial dimensions. It was used in our pilot study.
  • other subscales of the SF-36 [ Time Frame: 6 weeks, 6 months ]
    Health Related Quality of Life (HRQoL) is also assessed using other subscales of the SF-36v2, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. Scores are provided for each of these health domains, and two summary measures of physical and mental health: the Physical Component Summary (PCS) and Mental Component Summary (MCS).
  • Hospital Anxiety and Depression Scale [ Time Frame: 6 weeks, 6 months ]
    Anxiety and depression function will be measured using the Hospital Anxiety and Depression Scale (HADS). The HADS contains 14 statements and scores from 0-21. Scores of 8-10 indicate the possibility of anxiety or depression, and 11 and above indicate that these are likely to be present. It has been validated in the critical care population.
  • 'Readiness to change' questionnaire [ Time Frame: 6 weeks, 6 months ]
    Patient's readiness to exercise and self efficacy to exercise are important aspects of feasibility when commencing an exercise programme. Readiness to commence exercise following critical illness will be obtained by assessing components relating to the transtheoretical model (stages, processes, decisional balance, self-efficacy). There is evidence of reliability and validity of the questionnaires designed to measure these constructs.
  • Chronic Disease Self Efficacy Scale (Exercise component) [ Time Frame: 6 weeks, 6 months ]
    The exercise component of the Chronic Disease Self Efficacy Scale will be used to measure self efficacy relating to exercise.
  • The EuroQol-5D [ Time Frame: 6 weeks, 6 months ]
    The EuroQol-5D is a useful measure of health related quality of life in a mixed critical care population.
  • Medical Research Council Dyspnoea Scale [ Time Frame: 6 weeks, 6 months ]
    Breathlessness will be measured by the Medical Research Council dyspnoea scale. Breathlessness is a common problem encountered by these patients and an important patient focused outcome.
  • 'Healthcare Utilisation' Questionnaire [ Time Frame: 6 months ]
  • Semi-structured Interview [ Time Frame: 6 months ]
    Patient's perceptions of the exercise programme will be explored.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Exercise After Intensive Care Unit: a Randomised Controlled Trial
Official Title  ICMJE Effectiveness of a Programme of Exercise on Physical Function in Survivors of Critical Illness Following Discharge From the Intensive Care Unit (ICU): a Randomised Controlled Trial
Brief Summary The purpose of this study is to test if a 6-week programme of exercise improves physical function and health related quality of life in patients following intensive care who are discharged from hospital. In this study the investigators will compare the physical function and health related quality of life of patients who attend the programme with patients who do not. The 6 week exercise programme will be run by physiotherapy staff, and will mostly take place in a hospital gym. The investigators will measure patients' physical function, exercise capacity, level of breathlessness and their quality of life before and after the 6-week programme, and 6 months later. The investigators will also interview patients to ask their views about the acceptability, enjoyment and satisfaction with the exercise programme. If this study shows that the physical function and health related quality of life are improved in those who took part in the exercise programme, then it will provide useful information which will help the development of services for patients after critical illness. The results will also provide information which will help us design future clinical trials for this patient population.
Detailed Description

Most critically ill adult patients require ventilatory support during their intensive care unit stay. Following discharge home patients often still suffer from reduced physical function, exercise capacity, health related quality of life and social functioning for at least 2 years. There is usually no support to address these longer term problems specific to critical illness for patients after hospital discharge. Little research has been carried out into interventions which could improve physical function and quality of life, or enhance speed of recovery in these patients. While there is evidence to support the rehabilitation of critically ill patients within intensive care units, there is a paucity of literature to support rehabilitation following discharge from intensive care and hospital. Therefore, there is a clear and urgent need to investigate interventions which could improve the recovery of patients discharged home after intensive care. This is emerging as a prominent therapeutic objective for the future for this population.

This study will investigate whether a programme of exercise following discharge from hospital will improve outcome in patients following critical illness compared to standard care.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Critical Illness
  • Intensive Care
Intervention  ICMJE
  • Other: Exercise Programme

    Patients will complete three exercise sessions per week (2 supervised and 1 unsupervised) for 6 weeks. They will receive a written exercise manual which facilitates completion of their exercise programme. The exercise programme will consist of a warm-up, an exercise circuit, a period of aerobic exercise, and a cool down. The programme will be tailored to each patient's ability and needs.

    At the end of the 6 weeks patients will receive a short consultation to set goals relating to continuing exercise at home.

  • Other: Standard Care
    Following ICU admission patients are discharged to hospital wards to the care of a consultant, and the patients are no longer under the care of the ICU team. They are provided with appropriate medical and nursing care, and with referral to other disciplines as necessary. One mobile and able to return home to a carer or another facility they are discharged from hospital. There is usually no support to address potential problems specific to critical illness for patients after ICU discharge.
Study Arms  ICMJE
  • Experimental: Exercise programme
    Intervention: Other: Exercise Programme
  • Standard Care
    Intervention: Other: Standard Care
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 11, 2015)
60
Original Estimated Enrollment  ICMJE
 (submitted: November 1, 2011)
68
Actual Study Completion Date  ICMJE April 2015
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • age ≥ 18 years
  • ICU admission requiring mechanical ventilation > 96 hours
  • planned discharge to home (self-care/carer)
  • willing and able to participate in exercise
  • deemed medically fit to take part in the intervention

Exclusion Criteria:

  • declined consent or unable to give consent
  • inability to participate due to e.g. any neurological, spinal or skeletal dysfunction affecting ability to exercise
  • cognitive impairment affecting ability to understand the intervention or complete questionnaires
  • participation in another rehabilitation programme due to ongoing chronic disease
  • other medical contraindication to participation in an exercise programme
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01463579
Other Study ID Numbers  ICMJE 11/0291
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Brenda O'Neill, University of Ulster
Study Sponsor  ICMJE University of Ulster
Collaborators  ICMJE Belfast Health and Social Care Trust
Investigators  ICMJE
Principal Investigator: Dr Brenda O'Neill, PhD, BSc Hons Physiotherapy University of Ulster
PRS Account University of Ulster
Verification Date December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP